COVID-19 Clinical Trial
Official title:
A Phase I-II, Double-blind, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults
The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | October 23, 2024 |
Est. primary completion date | March 23, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Healthy volunteers aged 18 to 75 years on the day of inclusion 2. Participant signed informed consent 3. Residing in Philippines. 4. A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening. 5. A participant can be included providing, the participant haven't received any vaccination against COVID-19 in the past, or if the participant had already received any of the following licensed vaccines against COVID-19: Oxford/AstraZeneca; Pfizer/BioNTech; Moderna; or J&J/Janssen, with the participants last dose received at least 6 months prior the inclusion in this trial. Exclusion Criteria: 1. Participant is pregnant, lactating, or of childbearing potential 2. Participation in the 6 months preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure 3. Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study. 4. Receipt of any vaccine in the three months preceding the first trial vaccination or planned receipt of any vaccine in the 6 months following last trial vaccination. 5. Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination 6. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months 7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy 8. Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C 9. Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines or to a vaccine containing any of the same substances 10. Current alcohol abuse or drug addiction (reported or suspected) 11. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 12. Thrombocytopenia or any coagulation disorder 13. Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (i.e. in the employment of the clinical trial sites). 14. Refusal to be informed if relevant results concerning the participant's health are revealed |
Country | Name | City | State |
---|---|---|---|
Philippines | Health Index Multispecialty Clinic, Barangay Toclong 2B | Imus | Cavite |
Philippines | Tropical Disease Foundation | Makati City | National Capital Region |
Lead Sponsor | Collaborator |
---|---|
Emergex Vaccines Holding Ltd. |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the safety, tolerability and reactogenicity of the vaccine | Occurrence of solicited local reactogenicity signs and symptoms up to 7 days after each injection. Occurrence of solicited systemic reactogenicity signs and symptoms up to 14 days after each injection. Occurrence of unsolicited adverse events, serious adverse events (SAEs), and adverse events of special interest (AESI) up to 6 months following first vaccination or End Of Study (EOS), whichever is later. | 6 months following first vaccination or End Of Study (EOS), whichever is later | |
Secondary | Assess the cellular immunogenicity of the vaccine candidate | Proportion of participants with T cells specific to PepGNP-COVID19 vaccine, and Proportion of subjects with activated cellular immunity cells via assessment of peptide-specific T cell response performed by cytometry, using dextramer staining and, by measuring activation markers upon stimulation with peptides | 180 days following first vaccination | |
Secondary | Assess the humoral immunogenicity of the vaccine candidate | For individuals seronegative at enrolment - Proportion of participants becoming seropositive (antibodies against SARS-CoV-2 as determined by Enzyme-linked Immunosorbent Assay (ELISA)), and For individuals seropositive at enrolment - Fold change in anti-SARS-CoV-2 antibodies as determined by Enzyme-linked Immunosorbent Assay (ELISA) | 180 days following first vaccination |
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